Spine surgery showdown: which Tiny-Incision procedure wins for seniors?

NCT ID NCT07482826

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Expanded access (not trials)

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of keyhole spine surgery for middle-aged and older adults with lumbar spinal stenosis, a condition that causes leg pain and trouble walking. One surgery just removes the tissue pressing on nerves, while the other also fuses the bones together. The goal is to see which approach provides better pain relief and recovery with fewer risks.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged between 50 and 75 years, regardless of gender. 2. A definitive diagnosis of lumbar spinal stenosis, presenting with typical clinical symptoms (e.g., lower extremity radiating pain, neurogenic claudication) and signs, confirmed by imaging (MRI or CT). 3. The lesion involves only a single spinal segment (L2-S1). 4. Failed to respond to at least three months of systematic conservative treatment, with a significant impact on quality of life, and the patient has a clear willingness to undergo surgery. 5. (Clinical equipoise) After evaluation by at least two senior spine surgeons, both agree that the patient's condition meets the surgical indications for both full-endoscopic decompression and endoscopic lumbar interbody fusion. 6. The patient fully understands the randomized nature of this study (including random assignment and the relinquishment of choice by both the physician and the patient) and voluntarily signs the Informed Consent Form. Exclusion Criteria: 1. Clear indications for fusion: Degenerative spondylolisthesis greater than Meyerding Grade I, presence of lumbar spondylolysis, or evidence of definite lumbar instability on flexion-extension radiographs (e.g., segmental translation \> 3 mm or angular change \> 10°). 2. Clear indications for decompression alone: Stenosis caused solely by soft disc herniation, without concomitant bony spinal canal or lateral recess stenosis. 3. Spinal stenosis due to non-degenerative causes: Presence of spinal stenosis caused by fracture, spinal tumor, active infection, or inflammatory disease (e.g., ankylosing spondylitis, rheumatoid arthritis). 4. Severe spinal structural abnormalities: Presence of severe spinal deformity (e.g., degenerative scoliosis with a Cobb angle \> 20°). 5. History of relevant prior surgery: Previous lumbar surgery at the same or an adjacent segment. 6. Systemic diseases precluding tolerance to surgery: Presence of severe dysfunction of major organs (e.g., heart, lung, liver, kidney) or an American Society of Anesthesiologists (ASA) classification \> III, indicating an inability to tolerate anesthesia or surgery upon evaluation. 7. Comorbidities that may confound outcome assessment: Presence of other conditions that could cause lower extremity claudication or dysfunction, such as severe hip or knee osteoarthritis (including a history of total hip or knee arthroplasty), peripheral vascular claudication, or polyneuropathy. Presence of other neurological or muscular system disorders that could seriously affect treatment evaluation (e.g., Parkinson's disease, amyotrophic lateral sclerosis). 8. Participation in other studies: Currently participating in other clinical trials that could potentially influence the results of this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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